India mandates prescription for syrups, ending OTC sales

The Indian government has mandated that all syrups, including cough syrups, can no longer be sold without a doctor's prescription, ending their over-the-counter availability nationwide. The regulatory change, which took effect immediately upon its publication in the Official Gazette on June 9, 2026, was enacted through an amendment to the Drugs Rules, 1945.

The amendment removes the word "syrups" from a list of exempted medicines in Schedule K of the Drugs Rules. This list had previously allowed certain drugs to be sold without full compliance with retail licensing provisions. Officials stated the move is intended to bring syrup-based formulations under stricter regulatory oversight, enhance traceability, and ensure manufacturers and sellers comply with stricter licensing and quality-control requirements.

A significant effect of the change is that it also ends a specific exemption that permitted the sale of cough syrups in villages with a population of less than 1,000 without standard retail licensing. Now, all sales must occur through duly licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940.

The decision follows a draft notification issued in December 2025,...